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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289850551
Basic UDI-DI: 69332898CE3186FW
Reference: WK51
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 06.08.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

botissCARE Rapi-D™ Quantitative Vitamin D Test

1156Q-25

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Affimedix, Inc.
Manufacturer SRN: US-MF-000053178
UDI-DI: 00850082432042
Basic UDI-DI: B-00850082432042
Reference: 1156Q-25
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 06.08.2026 06:57

Manufacturer products Authorised representative products Authorised representative actors View details

Vitamin D Control – botiss CARE Rapi-D™ Quantitative Vitamin D Test

1156-VDC

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Affimedix, Inc.
Manufacturer SRN: US-MF-000053178
UDI-DI: 00850082432172
Basic UDI-DI: B-00850082432172
Reference: 1156-VDC
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 06.08.2026 06:57

Manufacturer products Authorised representative products Authorised representative actors View details

Tisenc Interleukin-6 (CLIA)

Interleukin-6 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitReagentSingle use

Manufacturer: Shenzhen Tisenc Medical Devices Co., Ltd.
Manufacturer SRN: CN-MF-000022936
UDI-DI: 06971824209167
Basic UDI-DI: B-06971824209167
Reference: W90C
EMDN: W01030606
EMDN description: OTHER INTERLEUKINS (EXCEPT FOR IL-6)
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.08.2026 01:03

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-CL IgA CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359547185
Basic UDI-DI: 697015090000330H8
Reference: CMQ3705
EMDN: W0102100501
EMDN description: ANTI-CARDIOLIPIN ANTIBODIES
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 05.08.2026 16:27

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-CL IgM CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359547086
Basic UDI-DI: 697015090000329HP
Reference: CMQ3605
EMDN: W0102100501
EMDN description: ANTI-CARDIOLIPIN ANTIBODIES
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 05.08.2026 16:27

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-CL IgA CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359547161
Basic UDI-DI: 697015090000330H8
Reference: CMQ3703
EMDN: W0102100501
EMDN description: ANTI-CARDIOLIPIN ANTIBODIES
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 05.08.2026 16:20

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Anti-CL IgM CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359547062
Basic UDI-DI: 697015090000329HP
Reference: CMQ3603
EMDN: W0102100501
EMDN description: ANTI-CARDIOLIPIN ANTIBODIES
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 05.08.2026 16:19

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-CL IgG CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359546980
Basic UDI-DI: 697015090000328HM
Reference: CMQ3505
EMDN: W0102100501
EMDN description: ANTI-CARDIOLIPIN ANTIBODIES
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 05.08.2026 16:19

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-CL CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359546881
Basic UDI-DI: 697015090000327HK
Reference: CMQ3405
EMDN: W0102100501
EMDN description: ANTI-CARDIOLIPIN ANTIBODIES
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 05.08.2026 16:19

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-β2-GP1 IgM CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359546782
Basic UDI-DI: 697015090000324HD
Reference: CMQ3205
EMDN: W0102100503
EMDN description: ANTI-B2-GLYCOPROTEIN I ANTIBODIES
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 05.08.2026 16:19

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-β2-GP1 IgG CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359546683
Basic UDI-DI: 697015090000323HB
Reference: CMQ3105
EMDN: W0102100503
EMDN description: ANTI-B2-GLYCOPROTEIN I ANTIBODIES
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 05.08.2026 16:19

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-CCP IgG CLIA Microparticles

AutoLumo analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359543989
Basic UDI-DI: 697015090000116H4
Reference: CMQ1405
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 05.08.2026 16:19

Manufacturer products Authorised representative products Authorised representative actors View details

Aerobic Culture Bottle FA Plus

Automated Blood Culture system, Microbial Detection System and Automated Microbial Detection System.

IVD Class AIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359525817
Basic UDI-DI: 697015090000150H4
Reference: MC0311
EMDN: W0104010504
EMDN description: BOTTLES FOR AUTOMATED BLOOD CULTURE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 05.08.2026 16:19

Manufacturer products Authorised representative products Authorised representative actors View details

Anaerobic Culture Bottle FN Plus

Automated Blood Culture system, Microbial Detection System and Automated Microbial Detection System

IVD Class AIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359525831
Basic UDI-DI: 697015090000152H8
Reference: MC0315
EMDN: W0104010504
EMDN description: BOTTLES FOR AUTOMATED BLOOD CULTURE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 05.08.2026 16:19

Manufacturer products Authorised representative products Authorised representative actors View details

Aerobic Culture Bottle PF Plus

Automated Blood Culture system, Microbial Detection System and Automated Microbial Detection System

IVD Class AIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359525824
Basic UDI-DI: 697015090000151H6
Reference: MC0313
EMDN: W0104010504
EMDN description: BOTTLES FOR AUTOMATED BLOOD CULTURE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 05.08.2026 16:19

Manufacturer products Authorised representative products Authorised representative actors View details

Panorama Prenatal Screen Collection Kit

NAT-801141

IVD Class AIVDR 2017/746On the marketKitSingle use

Manufacturer: Natera, Inc.
Manufacturer SRN: US-MF-000024142
UDI-DI: 00850034244532
Basic UDI-DI: 0850034244NAT-801141JT
Reference: NAT-801141
EMDN: W050101010201
EMDN description: BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR
First on market country: Austria
Authorised representative: QbD RepS BV
Last updated: 05.08.2026 15:39

Manufacturer products Authorised representative products Authorised representative actors View details

Signatera Blood Collection Kit - Plasma for ctDNA

NAT-802422

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Natera, Inc.
Manufacturer SRN: US-MF-000024142
UDI-DI: 00850034244525
Basic UDI-DI: 0850034244NAT-802422KD
Reference: NAT-802422
EMDN: W050101010201
EMDN description: BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR
First on market country: Austria
Authorised representative: QbD RepS BV
Last updated: 05.08.2026 15:39

Manufacturer products Authorised representative products Authorised representative actors View details

Signatera Blood Collection Kit - Whole blood for germline

NAT-802419

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Natera, Inc.
Manufacturer SRN: US-MF-000024142
UDI-DI: 00850034244518
Basic UDI-DI: 0850034244NAT-802419KQ
Reference: NAT-802419
EMDN: W050101010201
EMDN description: BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR
First on market country: Austria
Authorised representative: QbD RepS BV
Last updated: 05.08.2026 15:39

Manufacturer products Authorised representative products Authorised representative actors View details

Prospera Transplant Assessment Collection Kit | Blood Sample

NAT-802305

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Natera, Inc.
Manufacturer SRN: US-MF-000024142
UDI-DI: 00850034244013
Basic UDI-DI: 0850034244NAT-802305K8
Reference: NAT-802305
EMDN: W050101010201
EMDN description: BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR
First on market country: Austria
Authorised representative: QbD RepS BV
Last updated: 05.08.2026 15:39

Manufacturer products Authorised representative products Authorised representative actors View details